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Found 6 results
510(k) Data Aggregation
(90 days)
AS A POWERED MUSCLE STIMULATOR
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- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy 2 .
- Increasing local blood circulation
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- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis
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- Maintaining or increasing range of motion
AS A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
- 1 . Symptomatic relief of chronic intractable pain
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device named GST-1, which functions as a Transcutaneous Electrical Nerve Stimulator (TENS) and a Powered Muscle Stimulator.
This document does not contain information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications for a study. The letter only confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.
Therefore, I cannot provide the requested information based on the given text.
To answer your request, clinical study reports or summaries, often found within the 510(k) submission itself (which is typically a much larger document than this letter), would be needed. This FDA letter is a regulatory approval notice, not a scientific study report.
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(93 days)
AS A POWERED MUSCLE STIMULATOR
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
AS A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
- SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
AS AN INTERFERENTIAL CURRENT STIMULATOR
- SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
- SYMPTOMATIC RELIEF OF ACUTE PAIN
Not Found
The provided document is an FDA 510(k) clearance letter for the MEDS-4-INF+ Stimulator, determining its substantial equivalence to legally marketed predicate devices. It lists the approved indications for use as a Powered Muscle Stimulator, a Transcutaneous Electrical Nerve Stimulator, and an Interferential Current Stimulator.
However, this document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, nor any of the other specific details requested in the prompt (sample sizes, ground truth, expert qualifications, etc.).
Therefore, I cannot provide the requested information based on the input document.
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(90 days)
SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
Not Found
I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a Neuromuscular Stimulator. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information. However, it does not contain any information about specific acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or performance metrics for the MEDS-4 Neuromuscular Stimulator itself. The document is primarily an administrative approval notice, not a detailed technical report of a clinical study.
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(90 days)
THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS : - Relaxation of muscle spasms 1. - 2. Prevention or retardation of disuse atrophy - Increasing local blood circulation 3 . - Muscle re-education 4 . - Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis - Maintaining or increasing range of motion 6.
MEDS-3 NEUROMUSCULAR STIMULATOR
The provided text is a 510(k) clearance letter from the FDA for the MEDS-3 Neuromuscular Stimulator. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that the device was compared against existing, similar devices already cleared for market, rather than undergoing a de novo study with explicit acceptance criteria.
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(90 days)
THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :
- 1 . Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
- 4 . Muscle re-education
- Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis
- Maintaining or increasing range of motion 6.
MEDS-4 NEUROMUSCULAR STIMULATOR
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "MEDS-4 Neuromuscular Stimulator." It confirms that the device is substantially equivalent to legally marketed predicate devices and lists the indications for use.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information based on the input text. The 510(k) clearance letter focuses on regulatory approval based on substantial equivalence to existing devices, not on a detailed presentation of performance study results against specific acceptance criteria.
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(90 days)
SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves the device meets those criteria, or any of the detailed aspects like sample sizes, expert qualifications, adjudication methods, or specific study types.
The document is a clearance letter from the FDA regarding a 510(k) premarket notification for the "MEDS-3 Neuromuscular Stimulator." It primarily states that the device has been determined to be substantially equivalent to a legally marketed predicate device for the symptomatic relief of chronic intractable pain. It outlines the regulatory classification and general controls applicable to the device but does not include performance data, study designs, or acceptance criteria.
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